Content about Biosimilar

January 18, 2011

Generic drug maker Sandoz has started a mid-stage clinical trial of a monoclonal antibody used to treat cancer and autoimmune disease, the company said.

HOLZKIRCHEN, Switzerland — Generic drug maker Sandoz has started a mid-stage clinical trial of a monoclonal antibody used to treat cancer and autoimmune disease, the company said.

Sandoz (pronounced “SAN-doh”), the generics arm of Swiss drug maker Novartis, announced the start of a phase-2 trial of rituximab, a biosimilar of Genentech’s Rituxan, used to treat such conditions as non-Hodgkin’s lymphoma and rheumatoid arthritis.

January 12, 2011

Drug maker Merck and drug industry services organization Parexel International will work together to develop biosimilars, the two said Wednesday.

WHITEHOUSE STATION, N.J. — Drug maker Merck and drug industry services organization Parexel International will work together to develop biosimilars, the two said Wednesday.

Under the agreement, Parexel will give Merck BioVentures access to clinical and regulatory services for the development of biosimilars. Financial terms of the agreement were not disclosed.

January 6, 2011

A U.S. biotech company plans to develop a biosimilar of a monoclonal antibody used to treat cancers and autoimmune disorders.

IRVINE, Calif. — A U.S. biotech company plans to develop a biosimilar of a monoclonal antibody used to treat cancers and autoimmune disorders.

Spectrum Pharmaceuticals announced Wednesday a deal with Viropro to develop a biosimilar rituximab, marketed under the brand name Rituxan by Roche’s Genentech division. Global sales of rituximab in 2009 were $5.6 billion, according to Spectrum.

December 20, 2010

Drugs for bacterial infections and cancer, and one that could help shape regulations for biosimilars, are featured in the Food and Drug Administration’s annual "Generic Drug Roundup."

SILVER SPRING, Md. — Drugs for bacterial infections and cancer, and one that could help shape regulations for biosimilars, are featured in the Food and Drug Administration’s annual "Generic Drug Roundup."

The roundup is an annual highlighting of what the agency considers the most significant generic drug approvals.

December 7, 2010

Drug makers Momenta Pharmaceuticals and Sandoz have filed a lawsuit against Teva Pharmaceutical Industries in the U.S. District Court for the District of Massachusetts, alleging infringement of two patents related to a generic blood-thinning drug.

CAMBRIDGE, Mass. — Drug makers Momenta Pharmaceuticals and Sandoz have filed a lawsuit against Teva Pharmaceutical Industries in the U.S. District Court for the District of Massachusetts, alleging infringement of two patents related to a generic blood-thinning drug.

November 14, 2010

William Gibson, the science-fiction author who helped create the cyberpunk genre in the 1980s and...

WALTHAM, Mass. — William Gibson, the science-fiction author who helped create the cyberpunk genre in the 1980s and paved the way for “The Matrix” movie franchise, once said, “The future is already here—it’s just not evenly distributed.”

He was correct. Emerging technologies, ranging from computers to mobile phones, historically have migrated from the theoretical to the inaccessible to the aristocratic to the indispensable and finally to the mundane.

November 9, 2010

To express it in modern parlance, follow-on biologics will be a hot mess....

NEW YORK To express it in modern parlance, follow-on biologics will be a hot mess.

 

While speaking at the Reuters Health Summit, according to Reuters, Food and Drug Administration commissioner Margaret Hamburg didn’t put it quite that colorfully, but she had said the science will evolve, meaning a regulatory approval pathway never will be a truly done deal.

 

 

November 2, 2010

The main lobbies for the biotechnology and generic drug industries, and a leading manufacturer of...

SILVER SPRING, Md. The main lobbies for the biotechnology and generic drug industries, and a leading manufacturer of generic drugs, testified Wednesday at a hearing sponsored by the Food and Drug Administration to collect public and industry input on the implementation of the regulatory approval pathway for follow-on biologics included in the healthcare-reform bill.

 

November 1, 2010

Amgen's SVP research and development, Joe Miletich, urged members of a Food and Drug Administration...

THOUSAND OAKS, Calif. Amgen's SVP research and development, Joe Miletich, urged members of a Food and Drug Administration panel to establish approval standards for biosimilars that ensure patient safety and follow a science-based approach.

“Put patients first and sound policy will follow,” Miletich said. “Amgen believes biosimilars have a meaningful role to play in the healthcare system. However, dissimilar — unlike generic drugs — are not identical to the innovative biological products.” 

November 1, 2010

In testimony before the Food and Drug Administration on Tuesday, CVS Caremark’s SVP specialty pharmacy...

WOONSOCKET, R.I. In testimony before the Food and Drug Administration on Tuesday, CVS Caremark’s SVP specialty pharmacy operations, Scott Reid, reiterated the company’s support that the FDA implement regulations necessary to approve biogeneric drugs under the Affordable Care Act.

November 1, 2010

The Food and Drug Administration should ensure patient access, safety and efficacy; create a transparent...

WASHINGTON The Food and Drug Administration should ensure patient access, safety and efficacy; create a transparent and scientific regulatory structure; and enable innovation and competition when creating regulations governing follow-on biologics, according to testimony released in advance of an FDA hearing by a drug lobbying group.

September 29, 2010

The Food and Drug Administration declined to approve a Teva biosimilar, the generic drug maker...

JERUSALEM The Food and Drug Administration declined to approve a Teva biosimilar, the generic drug maker said Thursday.

 

Teva said it received a complete response letter from the FDA concerning Neutroval (filgrastim), for neutropenia in patients receiving chemotherapy for cancer. The FDA issues complete response letters when it needs additional information before it can approve a drug.

 

 

Neutroval is a biosimilar of Amgen’s Neupogen and is marketed in Europe under the name TevaGrastim.

 

September 28, 2010

While biosimilars promise to provide therapies for a wide range of diseases, their biggest fans...

September 26, 2010

Biosimilars, biogenerics, follow-on biologics—whatever the designation one prefers for knockoffs of biotech drugs—they will soon...

September 26, 2010

Many generic drug companies have long marketed branded drugs on the side, but lately, some...

Many generic drug companies have long marketed branded drugs on the side, but lately, some branded drug companies have sought to enter the generics business as well. One of those companies is Meda Pharmaceuticals, the U.S. subsidiary of Swedish drug maker Meda AB. Drug Store News recently interviewed John White, Meda’s senior director of marketing.

Drug Store News: What gave Meda the idea of pursuing generics?

September 20, 2010

The Food and Drug Administration is looking for input on regulations concerning knock-off versions of...

WASHINGTON The Food and Drug Administration is looking for input on regulations concerning knock-off versions of biotech drugs, according to published reports.

 

The Hill, a newspaper in Washington, reported Monday that the FDA would have a hearing on Nov. 2 and 3 concerning follow-on biologics, based on a draft document distributed to healthcare lobbyists.

 

 

According to the report, the hearing would focus on such issues as interchangeability and definitions of such terms as “biological product.”

August 23, 2010

French drug maker Sanofi-Aventis is suing to stop Sandoz’ generic version of its blood thinner...

August 15, 2010

A lot of generic drug companies have conducted business in the branded drug market on...

SOMERSET, N.J. A lot of generic drug companies have conducted business in the branded drug market on the side for a long time, with Teva Pharmaceutical Industries and Watson Pharmaceuticals standing out as good examples. But lately, some branded drug companies have sought to get into generics as well.

 

Meda Pharmaceuticals, the U.S. subsidiary of Swedish drug maker Meda A.B., recently decided to create its own generics subsidiary, calling it Wallace Pharmaceuticals, senior marketing director John White told Drug Store News.

 

August 8, 2010

Generic drug maker Dr. Reddy’s has launched in India the world’s first follow-on version of...

August 2, 2010

Hospira had net sales of $968 million and profits of $83.5 million in second quarter...

July 20, 2010

Biosimilars may have cleared their biggest stretch of wilderness thanks to their inclusion in the...

July 14, 2010

Watson Pharmaceuticals will work with a venture-backed firm to develop a biosimilar treatment for female...

June 6, 2010

After nearly a decade at the helm, Generic Pharmaceutical Association president and CEO Kathleen Jaeger...

May 24, 2010

Generic drug maker Teva Pharmaceutical Industries isn’t holding back in its effort to push into...

May 13, 2010

Teva Pharmaceutical Industries could get a lot of business thanks to the health-reform law, according...